Fakta om udbudet

EU-nr

2020/S 104-251063

Offentliggjort

29.05.2020

Udbudstype

Forhåndsmeddelelse

Bestilling af materiale

https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-signalsystem-engelsk/

Udbyder

Lægemiddelstyrelsen

Pharmacovigilance System for Signal Detection and Management

Lægemiddelstyrelsen

Prior information notice

This notice is for prior information only

Services

Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority

I.1) Name and addresses

Official name: Lægemiddelstyrelsen
National registration number: 37052485
Postal address: Axel Heides Gade 1
Town: København S
NUTS code: DK01 Hovedstaden
Postal code: 2300
Country: Denmark
Contact person: Troels Mogensen
E-mail: trm@dkma.dk
Telephone: +45 44889344

Internet address(es):

Main address: http://www.lmst.dk

I.2) Information about joint procurement

I.3) Communication

The procurement documents are available for unrestricted and full direct access, free of charge, at: https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-signalsystem-engelsk/

Additional information can be obtained from the abovementioned address

I.4) Type of the contracting authority

Ministry or any other national or federal authority, including their regional or local subdivisions

I.5) Main activity

Health

Section II: Object

II.1) Scope of the procurement

II.1.1) Title:

Pharmacovigilance System for Signal Detection and Management

II.1.2) Main CPV code

72220000 Systems and technical consultancy services

II.1.3) Type of contract

Services

II.1.4) Short description:

The Danish Medicines Agency, DKMA, wishes to procure a system to aid in pharmacovigilance. At present we collaborate with the UK Medicines and Health Regulatory Agency (MHRA) and occupy a part of their system, Sentinel, which is due to retire. Given the unclear situation about Brexit, DKMA has seen it fit to pursue a market consultation with potential vendors about a system, that may eventually replace the functionalities we make use of in Sentinel. Be aware that this consultation is specifically regarding a signal management system. The market consultation will precede and inform the tender expected to be announced early next year. For further information, please see the link in section I.3).

Se also out earlier published consultation about the part of the same project that does not concern signal mangement: https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-bivirkningssystem-engelsk/

II.1.5) Estimated total value

II.1.6) Information about lots

This contract is divided into lots: no

II.2) Description

II.2.1) Title:

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

NUTS code: DK01 Hovedstaden

II.2.4) Description of the procurement:

Pharmacovigilance signal management system and associated IT-services. The system should preferably already be commercially available and require as little customer specific modification as possible.

II.2.14) Additional information

Estimated data of publication should be considered a rough estimate.

II.3) Estimated date of publication of contract notice:

15/02/2021

Section IV: Procedure

IV.1) Description

IV.1.8) Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: yes

Section VI: Complementary information

VI.3) Additional information:

VI.5) Date of dispatch of this notice:

27/05/2020